Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study

Part of paid clinical trials in Dallas, Texas.

Sponsor
Octapharma
Study ID
NCT05935358
Phase
PHASE4
Status
Recruiting
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Conditions

  • Severe Hemophilia A

Eligibility Criteria

Sex
MALE
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nuwiq — DRUG
    Nuwiq is a purified B-domain-deleted FVIII glycoprotein synthesised by a genetically engineered human embryonic kidney cell line (HEK 293F).

Study Details

Recombinant factor VIII for the prevention of bleeding in patients with severe haemophilia A undergoing major surgery while receiving emicizumab prophylaxis

Key Dates

Start date
Nov 28, 2023
Status verified
May 2026
Primary completion
Aug 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nuwiq
    All patients receiving Nuwiq (recombinant FVIII). Nuwiq will be administered intravenously in accordance with the relevant prescribing information. Treatment will be repeated as necessary every 8-24 hours until adequate wound healing, then - if required - for at least another 7 days to maintain FVIII plasma levels of 30-60 IU/dL.

Primary Outcome Measure

Overall haemostatic efficacy [ Time Frame: During surgery and until completion of wound healing (e.g. removal of sutures, cessation of drainage, etc.) as defined by the investigator, during the study duration of 30 ± 3 days after the day of surgical procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT Southwestern Medical CenterDallasTexas75390-

Find similar trials in Dallas, TX

By research site
UT Southwestern Medical Center· Dallas, TX

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